Study of Safety and Tolerability of EO2002 in the Treatment of Corneal Edema
Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
Corneal edema is the most common indication for corneal transplantation, accounting for
approximately 70% of penetrating keratoplasty (PK), and 100% of endothelial keratoplasty (EK)
procedures annually. There is currently no disease-modifying treatment for corneal edema.
Topical treatments like hypertonic saline are not effective on a long-term basis. For those
with advanced disease, where edema and vision loss are not controlled by topical treatment,
the only option is a corneal transplant. A potential approach to avoidance of the risks of
corneal transplantation is to inject cultured human corneal endothelial cells (HCECs) into
the anterior chamber of the eye. This approach may avoid surgery by re-populating the inner
most aspect of the cornea with functioning endothelial cells. Emmecell has developed a
treatment based on technology integrating biocompatible magnetic nanoparticles with cultured
HCECs to treat corneal edema in a minimally invasive way. The primary objective of this phase
1, prospective, multi-center, open-label, dose-escalation study is to evaluate the safety and
tolerability of 3 doses of EO2002 with and without endothelial brushing (EB) or Descemet
Stripping (DS) in eyes with corneal edema secondary to corneal endothelial dysfunction that
qualify for surgery involving full-thickness corneal transplantation or EK.